Analyzing metabolic pathways in hormone receptor positive breast cancer
Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
This study tests how a special glucose infusion during breast cancer surgery can help researchers understand the metabolism of hormone receptor positive breast cancer to improve future treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT05736367 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic activity of hormone receptor positive (HR+)/HER2 negative breast cancer by administering a U-13C-glucose infusion during routine breast cancer surgery. Participants will undergo tumor and blood sample collection to analyze the metabolic processes of the tumor. The study duration for each patient is three to four weeks, including a two to three hour glucose infusion and biopsy procedures. The goal is to gain insights into the tumor's metabolic behavior, which may inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals with early-stage hormone receptor positive/HER2 negative breast cancer who are scheduled for surgical resection.
Not a fit: Patients with triple negative or HER2 positive breast cancer, as well as those currently enrolled in other clinical studies involving investigational therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of breast cancer metabolism, potentially leading to more effective treatment options.
How similar studies have performed: While this approach is innovative, similar studies investigating metabolic pathways in cancer have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy. * Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0) * Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy). * Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection. Exclusion Criteria: * Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. * Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer. * Concomitant active malignancy * Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
Where this trial is running
New Brunswick, New Jersey and 1 other locations
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- RWJBarnabas Health — New Brunswick, New Jersey, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Coral Omene, MD, PhD — Cancer Institute of New Jersey Rutgers
- Study coordinator: Coral Omene, MD, PhD
- Email: co273@cinj.rutgers.edu
- Phone: 732-235-3374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.